Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K38/00—Medicinal preparations containing peptides
  • A61K38/01—Hydrolysed proteins; Derivatives thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P3/00—Drugs for disorders of the metabolism

Definitions

• the present invention is directed to amino acid compositions useful for enhancing protein anabolism and detoxification.
• the amino acid proportions of the blood plasma differ significantly from the profiles of either food proteins or the various body proteins. Pools of amino acids in body tissues are needed for normal anabolic function. This pool is normally replaced by the blood's supply of amino acids. The blood, in turn, draws from pools of free amino acids in other tissues to replace what has been used. Therefore plasma concentrations of amino acids remain relatively constant even the supply through dietary sources is deficient for any reason. Thus, the standard accepted total protein tests of the plasma do not provide an early warning of protein and amino acid deficiencies. Excess of some amino acids can produce results as detrimental as some deficiencies.
• the present invention is directed to a composition for enhancing protein anabolism.
• the composition comprises molybdenum and at least two amino acids selected from the group consisting of L-arginine, L-cystine, L-histidine. L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-threonine, L-tryptophan. L-tyrosine, and L-valine.
• the composition further comprises creatine monohydrate and/or sulfur, preferably in the form of methylsulfonylmethane.
• the composition comprises, based on the total weight of the composition: about 6% to about 9% by weight L-arginine. about 2% to about 4% by weight L-cystine. about 1.5% to about 3.5% by weight L-histidine, about 6% to about 9% by weight L-isoleucine, about 8% to about 12% by weight L-leucine, about 6% to about 8% by weight L-lysine.
• the amino acids are all free form amino acids.
• the amino acids can be provided in the form of powdered egg white or powdered milk, for example, in the event that free form amino acids are not available.
• the composition preferably further comprises a proteolytic enzyme.
• the composition of the invention is provided in the form of a powder, which is preferably encapsulated in a gelatin capsule.
• the invention is also directed to a method for enhancing protein anabolism in a patient comprising adrninistering to the patient an effective amount of a composition as described above.
• the composition is preferably administered orally.
• the composition is administered to the patient in an amount of from about 1.5 grams/day to about 15 grams/day, more preferably in an amount of from about 3 grams/day to about 10.5 grams/day.
• FIG. 1 is an illustration of the Voll Points on the foot, used in the Vickery-Voll Test.
• the present invention is directed to a composition for enhancing protein anabolism.
• the composition comprises molybdenum and at least two amino acids selected from the group consisting of L-arginine, L-cystine, L-histidine, L-isoleucine, L-leucine.
• Molybdenum activates enzymes in the liver that assist in and enhance the detoxification process.
• the molybdenum can be provided in any suitable form, for example, as sodium molybdate or etrathiolmolybdate.
• Kreb's available from Douglas Laboratories under the trade name VitaHealthy or from Monarch Nutrition, Utah
• VitaHealthy or from Monarch Nutrition, Utah is a complex formed from sodium molybdate, alphaketoglutaric acid, citric acid, fumaric acid, malic acid, succinate and dicalcium phosphate.
• the molybdenum is present in the composition in an amount of from about 0.001% to about 0.03% by weight, more preferably from about 0.0015% to about 0.01 % by weight, based on the total weight of the active ingredients in the composition.
• L-Arginine is desirable in the composition for stimulating the immune system and assisting in the utilization of other amino acids.
• L-Arginine has several other advantages, including blocking the formation of tumors, causing release of growth hormone, forming citrulline and ornithine by hydrolysis, detoxification of ammonia, assisting in liver regeneration, wound healing, growth and sperm formation, and lowering cholesterol.
• L-Arginine is preferably present in the composition in an amount ranging from about 6% to about 9% by weight, more preferably from about 7% to about 8% by weight, based on the total weight of the active ingredients in the composition.
• L-Cystine is convertible to and from cysteine.
• L-Cystine is believed to minimize the cross-linking of free radicals that age the skin, harden the arteries, deposit aging pigments, and cause arthritis and mutagenic disorders such as cancer. Additionally, L-cystine is the precursor of glutathione, the body's primary antioxidizer and detoxifier that protects against such substances as lead, mercury, radiation, pesticides, and tobacco smoke. L-Cystine is also important in red and white cell formation and facilitating oxygen transport. L-Cystine is preferably present in the composition in an amount ranging from about 2% to 4%, more preferably from about 2.5% to about 3.5%, based on the total weight of the active ingredients in the composition. L-Histidine is a necessary amino acid for neurotransmitter formation.
• L- histidine regulates blood sugar levels and affects allergic response.
• L-Histidine is preferably present in the composition in an amount of from about 1.5% to about 3.5% by weight, more preferably from about 2% to about 3% by weight, based on the total weight of the active ingredients in the composition.
• L-Isoleucine aids in wound healing and muscle growth. Additionally, L-isoleucine is critical to life in stress, energy and muscle metabolism. L-Isoleucine is preferably present in the composition in an amount of from about 6% to about 9% by weight, more preferably from about 7% to about 8% by weight, based on the total weight of the active ingredients in the composition. L-Leucine is useful for lowering blood sugar, stimulating protein synthesis in muscle, and wound healing of skin and bone. Additionally, L-leucine stimulates protein synthesis in muscle. L-Leucine is preferably present in the composition in an amount of from about 8% to about 12% by weight, more preferably from about 9% to about 11% by weight, based on the total weight of the active ingredients in the composition.
• L-Lysine is a critical enzyme in carbohydrate metabolism. L-Lysine is used in the treatment of he ⁇ es viruses and Parkinsons' Psychosis. Additionally. L-lysine builds connective tissue, collagen and bone and assists in calcium transport through the body. L-Lysine is preferably present in the composition in an amount of from about 6% to 8% by weight, more preferably from about 6.5% to about 7.5% by weight, based on the total weight of the active ingredients in the composition.
• L-Methionine is a sulfur-containing amino acid that removes heavy metals, quenches free radicals, and lowers cholesterol. L-Methionine also prevents fat accumulation in the liver and, along with cysteine/cystine, helps prevent disorders of the hair, skin, and nails. L-Methionine is preferably present in the composition in an amount of from about 2.5% to 4.5% by weight, more preferably from about 3% to about 4% by weight, based on the total weight of the active ingredients in the composition.
• L-Phenylalanine is useful for synthesizing insulin, adrenaline and certain enzymes. Additionally, L-phenylalanine enhances alertness, learning and memory and acts as a pain retardant and appetite suppressant. L-Phenylalanine also helps build collagen and connective tissues. L-Phenylalanine is preferably present in the composition in an amount of from about 5.5% to about 7.5% by weight, more preferably from about 6% to about 7% by weight, based on the total weight of the active ingredients in the composition.
• L-Threonine is useful as an immune booster. It degrades into glycine, serine, and glucose. L-Threonine is a wound healer and decreases the harmful effects of aspirin. L-Threonine is preferably present in the composition in an amount of from about 4.5% to about 6.5% by weight, more preferably from about 5% to about 6% by weight, based on the total weight of the active ingredients in the composition.
• L-Tryptophan is a precursor to melatonin and serotine. Additionally, L-tryptophan acts as an appetite suppressant, growth hormone stimulant and platelet clotting factor. L-Tryptophan can also be sued to treat insomnia, depression, migraine headaches, and high blood pressure. L-Tryptophan is preferably in the composition in an amount of from about 0.8% to about 3% by weight more preferably in an amount of from about 1.5% to about 2.5% by weight, based on the total weight of the active ingredients in the composition. If desired. 5-hydroxytryptophan can be used instead of L-tryptophan.
• L-Tyrosine is a precursor for dopamine, norepinephrine, thryoxin. catacholestrogens, melanin, and enkephalines. L-Tyrosine can be used as an antidepressant, a growth hormone promoter, an appetite suppressant, or an antioxidant. L-Tyrosine is preferably present in the composition in an amount of from about 4% to about 6% by weight, more preferably from about 4.5% to about 5.5% by weight, based on the total weight of the active ingredients in the composition.
• L-Valine aids in would healing, muscle growth and liver diseases.
• L-V aline is preferably present in the composition in an amount of from about 7% to about 10% by weight, more preferably from about 8% to about 9% by weight, based on the total weight of the active ingredients in the composition.
• each amino acid is preferably used in the base form.
• the amino acids are preferably in the form of free form amino acids.
• the amino acids can be provided in converted form.
• the converted amino acids can be supplied, for example, in the form of egg white powder or milk powder. If the amino acids are provided in converted form, preferably the composition further comprises a proteolytic enzyme in an amount of from about 15% to about 25%. based on the total weight of the active ingredients in the composition.
• the composition contains at least three, more preferably at least four, still more preferably at least five, and even more preferably at least six, of the above-listed amino acids. In a particularly preferred embodiment, the composition contains all of the above-listed amino acids. In another particularly preferred embodiment, the composition contains all of the above- listed amino acids except L-tryptophan.
• the composition further comprises creatine.
• Creatine is a natural body substance found to be distributed primarily in the skeletal muscle. Creatine assists in the replenishment of adenosine triphosphate, an energy source used in protein synthesis, in the muscles. Creatine has no known side effects.
• the creatine is in the form of creatine monohydrate.
• the creatine is present in the composition in an amount of from about 3% to about 30% by weight, more preferably from about 12% to about 22% by weight, based on the total weight of the active ingredients in the composition.
• the composition also comprises sulfur in addition to the sulfur provided in any of the amino acids.
• Sulfur is present in every cell of the body and is necessary for collagen synthesis. The body turns over approximately 850 mg of sulfur a day, resulting in a daily deficit. Food alone cannot always overcome this deficit.
• the sulfur can be provided in any suitable form, for example, as methylsulfonylmethane.
• sulfur is present in the composition in an amount of from about 1.5% to about 15%. more preferably from about 5% to about 10% by weight, based on the total weight of the active ingredients in the composition.
• methylsulfonylmethane is used as the source of sulfur, preferably the methylsulfonylmethane is present in the composition in an amount of from about 5% to about 45% by weight, more preferably from about 15% to about 30% by weight, based on the total weight of the active ingredients in the composition.
• a particularly preferred composition according to the invention comprises about 6% to about 9% by weight L-arginine, about 2% to about 4% by weight L-cystine, about 1.5% to about 3.5% by weight L-histidine, about 6% to about 9% by weight L-isoleucine, about 8% to about 12% by weight L-leucine, about 6% to about 8% by weight L-lysine, about 2.5% to about 4.5% by weight L-methionine, about 5.5% to about 7.5% by weight L-phenylalanine, about 4.5% to about 6.5% by weight L-threonine, about 4% to about 6% by weight L-tyrosine, about 7% to about 10% by weight L-valine, about 0.001% to about 0.03% by weight molybdenum, about 3% to about 30% by weight creatine, about 5% to about 45% by weight methylsulfonylmethane, and optionally about 0.8% to about 3% by weight L-tryptophan or 5-hydroxytryptophan,
• composition according to the invention comprises about 40% to about 55% by weight powdered egg white or powdered milk, about 15% to about 25% by weight of a proteolytic enzyme, about 20% to about 45% by weight methylsulfonylmethane, about 5% to about 15% by weight creatine, and from about 0.0015% to about 0.0050% by weight molybdenum, based on the total weight of the active ingredients in the composition.
• active ingredients refers to the following: L-arginine, L- cystine, L-histidine, L-isoleucine, L-leucine. L-lysine, L-methionine, L-phenylalanine, L- threonine, L-tryptophan, L-tyrosine, L-valine. molybdenum, creatine, creatine monohydrate, sulfur, and methylsulfonylmethane.
• active ingredients when used in connection with a composition comprising powdered egg white or powdered milk, the term also encompasses powdered egg white, powdered milk, and proteolytic enzymes.
• compositions according to the invention can be made by any suitable method known to those skilled in the art.
• the free form amino acids, as well as the methylsulfonylmethane, creatine monohydrate. and molybdenum are provided in the form of a powder.
• the powdered egg white, powdered milk and proteolytic enzyme are available in powder form.
• the desired amount of each component is measured and put into a large plastic bag.
• the plastic bag is sealed with a large amount of air remaining in the bag.
• the bag is then shaken and tossed for about ten minutes to thoroughly mix the composition.
• the components can be mixed in a large stainless steel mixer.
• the blended composition can then be provided in any suitable dosage form.
• the composition can be contained within gelatin capsules, preferably ones that do not deteriorate at room temperature, such as those made from beef or pork gelatin.
• Other suitable solid dosage forms can be used, including as tablets, capsules, caplets, granules, and bulk powders. Tablets can be compressed, tablet triturates, enteric-coated, sugar-coated, film-coated, multiply compressed or multiply layered containing suitable binder, lubricants, diluents, disintegrating agents, coloring agents, flavoring agents, and preservatives.
• Liquid dosage forms include aqueous and nonaqueous solutions, emulsions, suspensions and solutions and/or suspensions reconstituted from non-effervescent granules, containing suitable solvents, preservatives, emulsifying agents, suspending agents, diluents, sweeteners, coloring agents, and flavoring agents.
• suitable solvents preservatives, emulsifying agents, suspending agents, diluents, sweeteners, coloring agents, and flavoring agents.
• compositions can be administered to a patient by any suitable method, and are preferably administered orally or rectally.
• patient refers to any mammal, including humans, dogs and cats.
• a preferred dosage for adult humans is from about 1.5 grams/day to about 15 grams/day, more preferably from about 3 grams/day to about 10.5 grams/day, of the composition.
• the Vickery-Voll test is a simple test used to determine amino acid deficiencies.
• the three Voll Points are localized on the right foot, as shown in FIG. 1.
• a finger is placed on each point, one point at a time, and the right tensor fascia muscle is tested for weakening. Weakening of the muscle yields a positive result, indicating amino acid deficiencies.
• the HOG test is also used to determine amino acid deficiencies.
• the patient is placed on his back, with his left leg extended and raised to 45 degrees.
• the leg muscle is tested for strength.
• a positive result, i.e., weakness indicates inferred amino acid deficiencies and potential or active hypoglycemic state.
• the Gland Scan test is another amino acid deficiency test.
• the patient places his hands on Neuro Lymphatic points and alarm points.
• the patient's reflexes are read. Weakening of the muscle corroborates amino acid deficiencies and electrical polarity change in the glands tested.
• the BEV test is used to determine the presence of spinal disk lesions. Pressure is exerted on different areas of the patient's spine (cervical, lumbar and dorsal regions), and the patient bends his spine in each region in four different quadrants. The mid-deltoid muscle is tested for strength, with weakening evidencing the presence of spinal disk lesions.
• the BEV test is described in more detail in Vickery, The Collected Papers of the International College of Applied Kinesiology, Summer 1990-91, Vol. I, pages 224-234, the disclosure of which is inco ⁇ orated herein by reference.
• the Confirmatory Challenge Test is also used to determine the presences of disk lesions.
• a description of the Confirmatory Challenge Test is provided in Vickery, Collected Papers of the Members of the International College of Applied Kinesiology-U.S.A., Summer 1989-90, Vol. I, pages 259-266, the disclosure of which is inco ⁇ orated herein by reference.
• the Raglan Test is used to measure adrenal insufficiency.
• the patient's blood pressure is taken sitting, standing, and laying down.
• a drop in blood pressure when the patient goes from laying to sitting or from sitting to standing indicates adrenal insufficiency.
• composition was prepared by combinin
• the molybdenum was provided by Douglas Laboratories as a molybdenum composition comprising primarily dicalcium phosphate with a molybdenum complex containing sodium molybdate combined with alphaketoglutaric acid, citric acid, fumaric acid, malic acid, and succinate, to achieve a total molybdenum concentration of 1% by weight.
• Example 2 The patient had a lumbar facet risotomy in 1990 and left knee reconstruction in 1976 and was diagnosed with Crohn's disease. An MRI revealed disk herniation between L4-L5. Additionally, the patient had burning pain down the right leg (front) and severe back pain. Surgery was scheduled two days later.
• Example 3 A patient was troubled by fungus infection under both large toenails that no spray, ointment, or cream seemed to mitigate, despite a daily consumption of three grams of an enhanced amino acid formulation (containing all of the amino acids in the formulation of Example 1, but no molybdenum, sulfur or creatine monohydrate) and a full nutritional supplement spectrum of professional quality. Five months after starting on the formula described in Example 1 six to eight times per day, both toenails were pink and normal. The toenails were also softer and grew faster.
• an enhanced amino acid formulation containing all of the amino acids in the formulation of Example 1, but no molybdenum, sulfur or creatine monohydrate
• Bio Multi Plus multi-vitaminerals by Biotics Research Co ⁇ ., Houston, Texas
• Biotics Bioprotect antioxidant formula, Biotics Research Co ⁇ .
• NESS Formula 11 an enzyme C Complex, NESS, Riverside, Missouri
• Example 1 the patient began on a formulation as described in Example 1, beginning with one 750 mg capsule per day, gradually increasing to four capsules per day. The patient is now walking two miles a day and able to enter stores, hotels, and shopping malls. The patient now practices golf and will soon be playing again.
• This case demonstrates the increased detoxification ability of the formulation of Example 1 through increased sulfate metabolism in the liver as well as its tissue rebuilding aspect.
• the above descriptions of exemplary embodiments of compositions and methods for enhancing protein anabolism are for illustrative pu ⁇ oses. Because of variations which will be apparent to those skilled in the art, the present invention is not intended to be limited to the particular embodiments described above. The scope of the invention is defined in the following claims. Further, it should be understood that the composition of the invention can function in accordance with the practice of the invention in the absence of any elements or materials not specifically described herein as being part of the composition.

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• 1999
  • 1999-05-24 US US09/317,595 patent/US6203820B1/en not_active Expired - Lifetime
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